A Open-Label Phase 3, Multi-Center, Parallel Group Study to evaluate Efficacy and Safety of GK664S in Subjects with moderate-to-severe scalp Eczema Dermatitis except for seborrheic dermatitis.

A Open-Label Phase 3, Multi-Center, Parallel Group Study to evaluate Efficacy and Safety Study of GK664S in Subjects with moderate-to-severe scalp Eczema Dermatitis except for seborrheic dermatitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224185

Enrollment

Registered

2018-12-11

Start date

2019-01-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scalp eczema dermatitis except for seborrheic dermatitis

Interventions

investigational material(s) Generic name etc : GK664S INN of investigational material : Clobetasol propionate Therapeutic category code : 264 Analgesics, anti-itchings, astrigents and anti-inflammator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with Scalp eczema dermatitisexcept for seborrheic dermatitis

Exclusion criteria

Exclusion criteria: (1)Subjects with a history of any of the following diseases 1)Serious drug allergy (shock, anaphylactic symptoms) 2)Allergy to corticosteroid 3)Cutaneous hypersensitivity to topical medicines (such as contact dermatitis) (2)Subjects with the Clinically significant liver, kidney, heart, or lung diseases that require hospitalization

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of subjects with an IGA score of 0(clear) or 1(almost clear) and achieving >=2 grade improvement from Baseline at week4 Investigators assess the IGA score of the scalp eczema dermatitis from symptoms across the scalp.	—

Secondary

Measure	Time frame
efficacy Change from Baseline in individual sign scores of scalp eczema dermatitis and pruritus score Investigators will assess the individual sign scores of scalp eczema dermatitis and let the subject evaluate pruritus score of scalp eczema dermatitis.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026